Kornimate/medical-research-clean huggingface dataset:
pilot sleep extension and mood

Conditions: Internalizing Mental Health Symptoms; Sleep Problems

Summary: the goal of this interventional study is to learn if a digital sleep extension intervention can improve sleep and mood in young urban adults with mood symptoms. the main questions it aims to answer are: will this intervention improve sleep? will this intervention improve mood? does the effect of this intervention change based on environmental factors like noise and light pollution? researchers will compare participants receiving the sleep intervention to participants receiving a "general healthy living" intervention to see if outcome are different across groups. participants will: * receive 6 weeks of brief once weekly telephone coaching and read once weekly educational content * have their sleep monitored daily with a fitbit and somnofy sleep device and during the 6-week intervention period * respond to questionnaires at the start of the intervention, halfway through the intervention, at the end of the intervention, and finally 4 weeks after completing the intervention


Eligibility criteria:
inclusion criteria: * age 18 to 30 * have internalizing symptoms (e.g., depression, anxiety, stress) * have sleep concerns * sleep less than 7 hours per night * have perceived neighborhood disorder * smart phone that can run somnofy app * access to wifi in their home exclusion criteria: * high risk for obstructive sleep apnea * significant medical morbidities or psychiatric problem, or chronic substance use * non-english speaking (unable to participate in therapy or questionnaire) * taking medications for sleep * an insomnia disorder * traveling for 2 weeks or more during the 10-week study period (due to loss of data from participants not sleeping in their home where the somnofy device has been set up) * employed with rotating shift or night work

Keywords: young adults sleep mood anxiety depression sleep extension stress
nasal bridle versus nasal patch for fixation of nasoenteral feeding tubes

Conditions: Feeding Tube Complication; Feeding Disorders

Summary: aim of this study is to compare fixation of nasoenteral feeding tubes using either a nasal patch or a nasal bridle in clinical patients with regard to the occurrence of tube dislocation, complications, and discomfort. 78 (2 \* 39) eligible patients will be included in this randomized controlled trial. the study is executed in two general teaching hospitals in the netherlands (gelre hospitals apeldoorn and medical spectrum twente).


Eligibility criteria:
inclusion criteria: * adult patient (18 years or older) * received a nasoenteral feeding tube while being hospitalized * providing written informed consent exclusion criteria: * contraindication for a nasal bridle (e.g., cleft lip or damaged nasal mucosa) * clinical need to place a nasal bridle * anticipated feeding nasoenteral feeding tube placement for \< 3 days * failure of nasoenteral feeding tube placement
a study of itolizumab in combination with corticosteroids for the first-line treatment of acute graft versus host disease (equator)

Conditions: Graft Versus Host Disease; GVHD; Acute-graft-versus-host Disease; Acute GVHD; aGVHD

Summary: this is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with grade iii-iv agvhd or grade ii with lgi involvement, in combination with corticosteroids

this study will enroll 200 subjects at approximately 125 sites globally. subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. the study follows the patients for a total of approximately 365 days.

Eligibility criteria:
inclusion criteria: 1. is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study. 2. is age ≥12 years and \>40kg at informed consent/assent. 3. has had an initial allogeneic hsct for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis. 4. has evidence of myeloid engraftment 5. has a clinical diagnosis of agvhd grades iii-iv or grade ii with lgi involvement based on mount sinai acute gvhd international consortium (magic) grading criteria. 6. began systemic corticosteroid treatment for agvhd ≤72 hours prior to the start of study drug dosing and must receive 2 mg/kg/day methylprednisolone or equivalent on day 1. exclusion criteria: 1. evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast. 2. an unplanned donor lymphocyte infusion for persistent or recurrent malignancy after hsct. 3. evidence of persistent molecular disease requiring treatment that was not specified prior to hsct. 4. evidence of cgvhd or overlap syndrome 5. use of immunosuppressants other than corticosteroids for the treatment of agvhd. 6. use of any systemic corticosteroids of \>0.5 mg/kg/day methylprednisolone or equivalent for any indication other than agvhd within 7 days before the onset of agvhd.
concentrated exposure therapy for post-traumatic stress disorder - a cohort study

Conditions: PTSD

Summary: post-traumatic stress disorder (ptsd) is a prevalent and disabling condition. trauma-focused psychotherapy, including cognitive behavioural therapy (cbt), are among the recommended first-line treatment alternatives. however, a substantial proportion of patients decline, drop-out or do not respond to current psychotherapies. previous research suggests that intensive or concentrated formats of trauma-focused psychotherapy can lead to faster recover and lower attrition, but there are currently few studies of these approaches. the current study will investigate the acceptability. treatment satisfaction and preliminary changes in symptoms after four consecutive days of concentrated cbt for ptsd.

the study will investigate the research questions in three stages. in the first stage four patients will be treated individually. in the second stage two groups of four patients will be treated, with at least a 1:1 ratio between therapists and patients per group. in the third stage 30 patients will be treated in groups of about four patients per group, with at least a 1:1 ratio between therapists and patients per group. the primary outcome measure is changes in ptsd-related symptoms as measured using the clinician-administered ptsd scale for dsm-5 (caps-5). acceptability will be measured as the proportion of patients accepting treatment when offered, while attrition is measured as the proportion of patients that withdraw from treatment after it has started. several other measures will be collected to measure treatment satisfaction, related symptoms, and functional impairment.

Eligibility criteria:
inclusion criteria: * fulfills dsm-5 criteria for ptsd * one or more single traumas in adolescence or adulthood * speaks and writes norwegian exclusion criteria: * new or unstable psychopharmacological treatment within last four weeks * fulfills icd-11 criteria for complex ptsd * ongoing substance abuse * ongoing danger of suicide * ongoing borderline personality disorder * ongoing psychosis * intellectual disability

Keywords: cbt caps group therapy psychotherapy treatment satisfaction
effect of fermented protaetia brevitarsis seulensis powder on alcohol-induced liver disease

Conditions: Alcoholic Liver Disease

Summary: the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of fermented protaetia brevitarsis seulensis powder on alcohol-induced liver disease in adults for 8 weeks.

previous studies have indicated that fermented protaetia brevitarsis seulensis powder may have the ability to improve liver function in adults with alcohol-induced liver disease. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of fermented protaetia brevitarsis seulensis powder on liver function in adults with alcohol-induced liver disease; the safety of the compound are also evaluate. the investigators examine gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, and other metabolic parameters at baseline, as well as after 4 and 8 weeks of intervention. sixty adults were administered either 4,000 mg of fermented protaetia brevitarsis seulensis powder or a placebo each day for 8 weeks.

Eligibility criteria:
inclusion criteria: * gamma-glutamyl transferase ranging from upper limit of reference to four times of upper limit exclusion criteria: * abnormal liver or renal function (i.e., serum aminotransferase activity \> 3 times of upper limit of reference range and serum creatinine concentrations \> 1.2 mg/dl) * diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dl) * history of viral hepatitis or cancer * uncontrolled hypertension * history of serious cardiac disease such as angina or myocardial infarction * history of gastrectomy * history of medication for psychiatric disease * administration of oriental medicine including herbs within the past 4 weeks
prevalence and environmental factors for myopia among chinese school-aged children and adolescent in tianjin

Conditions: Myopia; Refractive Errors

Summary: the high prevalence of myopia has become a global public health problem. the study amied to investigate the prevalence and progression of myopia associated with social environmental factors in tianjin, a chinese megacity in north china.

the high prevalence of myopia has become a global public health problem, especially in east and south asian countries. it's still not clear for the prevalence and progression of myopia associated with social environmental factors. thus, the investigators will conducted a long-term observational study to the effect of the socioeconomics, medical resources and school-related environmental parameters and others on the prevalence and progression of myopia among chinese school-aged children and adolescent.

Eligibility criteria:
inclusion criteria: * aged 6 to 18 years * no ocular diseases and systemic diseases * consent to undergo an eye examination exclusion criteria: * schoolchildren unwilling to participate

Keywords: myopia socioeconomics
complications of endocrine surgery: data from the united healthsystem consortium

Conditions: Thyroid Disease; Parathyroid Disease; Endocrine Gland

Summary: the goal of this study is to help better determine the complication rates for endocrine surgery across the nation for both benign and malignant disease. it is our hypothesis that the complication rates are low overall and that malignant disease results in a higher complication rate than benign disease. this study will do a database review from all university healthsystem consortium (uhc).


Eligibility criteria:
inclusion criteria: * all patients between the ages of 18 and 90 years who have a diagnosis of benign multinodular goiter and/or malignant thyroid disease and have undergone a total thyroidectomy as a primary procedure. * parathyroid patients will also be studied. exclusion criteria: * non endocrine surgery patients
a study of olaratumab (ly3012207) in participants with soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this study is to evaluate potential biomarkers and method of action, efficacy and safety of olaratumab in participants with soft tissue sarcoma (sts).


Eligibility criteria:
inclusion criteria: * have a histologically confirmed diagnosis of sts for which olaratumab and doxorubicin would be appropriate therapy. participants with a diagnosis of grade 1 liposarcoma are eligible if there is histological or radiographic evidence of evolution to more aggressive disease. participants with kaposi's sarcoma and gastrointestinal stromal tumors (gist) will be excluded. participants must have potentially resectable disease (as assessed by the study investigator) and have a primary tumor lesion deemed amenable to serial biopsy. * for radiotherapy addendum only: have a histologically confirmed diagnosis of sts of the extremities, grade 2 or 3, \>5 centimeters, for which olaratumab and radiotherapy would be appropriate therapy. participants with kaposi's sarcoma, gist or myxoid liposarcoma will be excluded. * have consented to undergo mandatory serial peripheral whole blood and tumor tissue sampling. exclusion criteria: * have active central nervous system (cns) or leptomeningeal metastasis (brain metastasis) at the time of enrollment. participants with a history of a cns metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that have not progressed on follow-up imaging, have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants, are eligible. participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment to rule out brain metastasis. * have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines or anthracenediones; the participant has received treatment with olaratumab or has participated in a prior olaratumab trial. * for radiotherapy addendum only: have received previous radiotherapy in the primary tumor lesion and/or prior treatment with olaratumab or has participated in a prior olaratumab trial.
physiotherapy in hematopoietic stem cell transplantation

Conditions: Hematologic Malignancy; Stem Cell Transplantation

Summary: research project with patients undergoing allogeneic hematopoietic transplantation in the hematology and hemotherapy clinical hospital universitario virgen de la arrixaca. the main objective is to assess the differences in skeletal muscle and functional variables in the experimental group underwent a physiotherapy treatment that takes place during the pre-and post-transplant period, compared to a control group.

the main characteristics of the study are: * randomized, prospective and longitudinal in patients receiving allogeneic hematopoietic stem cell transplantation clinical trial. * a descriptive study of skeletal muscle characteristics of patients undergoing allogeneic hematopoietic transplantation for hematologic malignancies before and after carrying out a treatment with stem cells. * clinical study of the variables of strength, mobility, proprioception and upper and lower pain in patients with hematologic malignancy member before and after cancer treatment. * clinical study of the effectiveness of physiotherapy treatment in clinical characteristics (strength, mobility, proprioception and pain) in patients undergoing allogeneic stem cell transplantation. * clinical study of psychosocial variables that are affected by hematological treatment, and the influence on them of a physiotherapy treatment. the data obtained in this project to identify and treat those functional deficits that appear as a result of cancer treatment and influencing patients, regarding the evolution of the disease and its treatment. they will use different psychosocial questionnaires and functional tests based on scientific evidence and the reliability of these, as well as its specific design for patients with hematologic cancer.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 70 years. * patients with a diagnosis of hematologic malignancy that will be subjected to hematopoietic transplantation. * patients offer sufficient guarantee adherence to protocol. * patients who have previously signed informed consent. exclusion criteria: * patients with inability to walk, before treatment. * patients whose medical judgment contraindicated inclusion in a physiotherapy intervention. * patients with psychotic traits, brain damage or senility prevention of the correct understanding of physical therapy. * patients with inability to sign informed consent or understanding.

Keywords: stem cell transplantation fatigue physiotherapy quality of life cancer psychosocial aspects
clinical validation of omron wheezescan

Conditions: Asthma in Children; Bronchitis; Bronchiolitis

Summary: the wheezescan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate pulmotrack device model 2020.


Eligibility criteria:
inclusion criteria: mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible. 1. does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis? 2. is the subject between the ages of 3 months to 8 years old? 3. is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf. exclusion criteria: the subjects will be excluded from the study, if they have any of the following criteria. 1. does the subject have skin rashes or wounds on the chest? 2. does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin? 3. does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)? 4. does the subject have an allergy to disinfecting alcohol? 5. does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, tracheomatosis? 6. does the subject have a heavy runny nose? 7. is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection? 8. is the subject having difficulty breathing or having severe symptoms? 9. was the subject enrolled more than once for the same resulted breath sounds? * note: the subject maybe enrolled once per arm (once wheezing, once non-wheezing).

Keywords: wheeze rhonchus
safety, pharmacokinetics, and efficacy of bepotastine besilate nasal product after ragweed pollen exposure in an environmental chamber

Conditions: Seasonal Allergic Rhinitis

Summary: the purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.


Eligibility criteria:
inclusion criteria: * subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen exclusion criteria: * no active respiratory tract infection
a clinical study to evaluate the effects of akkermansia muciniphila and berberine on prediabetes among obese subjects.

Conditions: Prediabetes

Summary: the akkermania muciniphila may play an important role in the occurrence and development of prediabetes. the purpose of this study was to evaluate the safety and efficacy of akk in the treatment of prediabetes among obese patients. in this study, a single center, randomized, double-blind, placebo-controlled design is adopted. 90 obese subjects with prediabetes are included in this study, and are allocated to akk group, bbr group, and placebo group at a ratio of 1:1:1. the study treatment lasts for 12 weeks. the changes of body fat, glucose metabolism, lipid metabolism indicators compared with the baseline at the end of the treatment will be analyzed. in addition, glucagon like peptide-1 (glp-1) and inflammatory markers (hscrp、tnf-α、il-6、il-8、il-1β) in blood will be analyzed before and after treatment. the changes in fecal flora structure and the akk bacteria also will be analyzed.


Eligibility criteria:
inclusion criteria: 1. aged 18-65 2. overweight/obesity (24.0≤bmi≤40.0 kg/m\^2) 3. fasting blood glucose ≥6.1 and \<7.0 mmol/l, or 2-hour postprandial blood glucose ≥7.8 and \<11.1 mmol/l, or glycosylated hemoglobin ≥5.7% and \<6.5% 4. fertile subjects (including male and female subjects) agreed to take effective contraceptive measures that the investigator accepted during and within 3 months after the trial (e.g. intrauterine device or a condom); the fertile female subjects with serum human chorionic gonadotropin test negative results within 7 days before the investigational product administration; infertile female must be surgically infertile or at least 1 year after menopause. 5. subjects should understand the nature, significance, potential benefits, inconvenience and risks of the study before the trial begins, fully understand and voluntarily sign the informed consent. exclusion criteria: 1. subjects who diagnosed with diabetes mellitus, medical obesity (excluding those who have been off medication for more than 1 year), or other secondary diabetes mellitus (e.g., cushing's syndrome, thyroid dysfunction, or acromegaly); 2. subjects who has undergone bariatric surgery; 3. subjects who has acute or chronic progressive or unstable disease, liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases; 3.subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months; 4.patients with hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency; 5.history of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months; 6.excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female) 7.pregnant or lactating subjects 8.subjects that the investigator considers need to excluded due to other causes.

Keywords: akkermania muciniphila obesity metabolism fecal flora prediabetes
lunar-4: effect of tumor treating fields (ttfields) (150 khz) concurrent with pembrolizumab for treatment of metastatic non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Summary: the purpose of the study is to test the effectiveness and safety of ttfields therapy, delivered using the novottf-200t device, concomitant with pembrolizumab in subjects with metastatic nsclc previously treated with a pd-1/pd-l1 inhibitor and platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * histologically or cytologically confirmed diagnosis of nsclc. * documented positive tumor pd-l1 expression (tps≥1%). * eastern cooperative oncology group (ecog) score of 0-1. * diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease. * subjects must have received one line of pd-1/pd-l1 inhibitor therapy for advanced or metastatic nsclc. pd-1/pd-l1 inhibitor may have been given alone or in combination with other therapy. * subjects who received pd-1/pd-l1 inhibitor for advanced disease, must have had a best response on pd-1/pd-l1 inhibitor of stable disease (sd), partial response (pr) or complete response (cr). * subjects must have experienced disease progression more than 84 days following cycle 1 day 1 (c1d1) of their most recent pd-1/pd-l1 inhibitor therapy. exclusion criteria - all individuals meeting any of the following exclusion criteria will be excluded from study participation: * mixed small cell and nsclc histology. * subject must not have leptomeningeal disease or spinal cord compression. * subject must not have untreated, symptomatic brain metastases, or residual neurological dysfunction. * subjects must not have received more than one line of pd-1/pd-l1 inhibitor for advanced disease. * subjects with a known sensitizing mutation for which the food and drug administration (fda)-approved targeted therapy for nsclc exists (e.g., egfr, alk, ros1) are excluded unless previously received at least one of the approved therapy(ies). * subjects with more than 2 lines of therapy in the advanced setting. * pregnant or breastfeeding. * implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso. * known allergies to medical adhesives or hydrogel.

Keywords: nsclc metastatic